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Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus (DJB)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Duodenal-jejunal Bypass
Sponsored by
Sound Shore Medical Center of Westchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established diagnosis of Type 2 diabetes mellitus
  • Body Mass Index(BMI) less than 35
  • Insulin usage duration less than 10 years
  • Negative anti-GAD
  • Fasting C-peptide level over 1.0 mcg/ml
  • Ability and willingness to follow up for a period of 1 year
  • Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators
  • Ability to understand and describe the risks, benefits and mechanism of action of the procedure

Exclusion Criteria:

  • Current pregnancy or positive pregnancy test
  • Liver Cirrhosis
  • Coagulopathy
  • Type 1 Diabetes Mellitus
  • HIV
  • Previous abdominal surgery preventing laparoscopy
  • Previous vagotomy
  • Previous gastric or small intestine surgery
  • Inability to comply with study requirements
  • Currently active medical malpractice lawsuit/s
  • Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis
  • Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma
  • Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon
  • Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria,
  • If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.

Sites / Locations

  • Sound Shore Medical Center of Westchester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DJB patient

Arm Description

Patient has undergone a duodeno-jejunal bypass

Outcomes

Primary Outcome Measures

Measure: Resolution of Type 2 Diabetes Mellitus

Secondary Outcome Measures

Measure: Safety and efficacy of duodenal-jejunal bypass

Full Information

First Posted
November 19, 2007
Last Updated
May 19, 2015
Sponsor
Sound Shore Medical Center of Westchester
Collaborators
Maffucci L, Rangraj M
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1. Study Identification

Unique Protocol Identification Number
NCT00562029
Brief Title
Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus
Acronym
DJB
Official Title
Modified Duodenal Switch Procedure "Duodenal-Jejunal Bypass" (Diabetes Surgery) As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Patients- a Pilot Project to Validate a Prospective Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sound Shore Medical Center of Westchester
Collaborators
Maffucci L, Rangraj M

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose and HbA1c in the abscence of medication support is possible with a surgical procedure named the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch procedure and is performed utilizing the laparoscopic approach.
Detailed Description
Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD) with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following the gastric bypass and over 95% for the duodenal switch. The clinical resolution of T2DM is defined as independence of all anti-diabetic medications and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight loss in all subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes Mellitus, Surgery, Duodenal Bypass, Resolution, Surgical Procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DJB patient
Arm Type
Experimental
Arm Description
Patient has undergone a duodeno-jejunal bypass
Intervention Type
Procedure
Intervention Name(s)
Duodenal-jejunal Bypass
Intervention Description
Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
Primary Outcome Measure Information:
Title
Measure: Resolution of Type 2 Diabetes Mellitus
Time Frame
One year
Secondary Outcome Measure Information:
Title
Measure: Safety and efficacy of duodenal-jejunal bypass
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of Type 2 diabetes mellitus Body Mass Index(BMI) less than 35 Insulin usage duration less than 10 years Negative anti-GAD Fasting C-peptide level over 1.0 mcg/ml Ability and willingness to follow up for a period of 1 year Willingness to consent for utilizing personal results without individual identifier information to be published in medical studies and other media as determined by the study investigators Ability to understand and describe the risks, benefits and mechanism of action of the procedure Exclusion Criteria: Current pregnancy or positive pregnancy test Liver Cirrhosis Coagulopathy Type 1 Diabetes Mellitus HIV Previous abdominal surgery preventing laparoscopy Previous vagotomy Previous gastric or small intestine surgery Inability to comply with study requirements Currently active medical malpractice lawsuit/s Diseases of the exocrine pancreas: pancreatitis trauma, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis Endocrinopathies: acromegaly, glucagonoma, Cushing's Syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldorestanoma Chemical Induced Diabetes: vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormones, diazoxide, beta-adrenergic agonists, thiazides, phenytoin, alfa-interferon Genetic Syndromes with Diabetes: Down's, Klinefelter's, Turner's, Wolfram, Lawrence-Moon- Beidel, Prader-Willi, Friederich's ataxia, Huntington's Chorea, Myotonic Dystrophy, Porphyria, If a candidate is deemed to be not an appropriate candidate based on investigators recommendation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Maffucci, MD
Organizational Affiliation
Sound Shore Medical Center of Westchester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhu S Rangraj, MD
Organizational Affiliation
Sound Shore Medical Center of Westchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sound Shore Medical Center of Westchester
City
New Rochelle
State/Province
New York
ZIP/Postal Code
10802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17060767
Citation
Rubino F, Forgione A, Cummings DE, Vix M, Gnuli D, Mingrone G, Castagneto M, Marescaux J. The mechanism of diabetes control after gastrointestinal bypass surgery reveals a role of the proximal small intestine in the pathophysiology of type 2 diabetes. Ann Surg. 2006 Nov;244(5):741-9. doi: 10.1097/01.sla.0000224726.61448.1b.
Results Reference
background
PubMed Identifier
15479938
Citation
Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. Erratum In: JAMA. 2005 Apr 13;293(14):1728.
Results Reference
background
PubMed Identifier
17386391
Citation
Cummings DE, Overduin J, Foster-Schubert KE, Carlson MJ. Role of the bypassed proximal intestine in the anti-diabetic effects of bariatric surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):109-15. doi: 10.1016/j.soard.2007.02.003. No abstract available.
Results Reference
result
PubMed Identifier
17386401
Citation
Cohen RV, Schiavon CA, Pinheiro JS, Correa JL, Rubino F. Duodenal-jejunal bypass for the treatment of type 2 diabetes in patients with body mass index of 22-34 kg/m2: a report of 2 cases. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):195-7. doi: 10.1016/j.soard.2007.01.009. No abstract available.
Results Reference
result
Links:
URL
http://ees.elsevier.com/soard/
Description
click here for information on background to present study

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Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus

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